Clinical Trials Coordinator
University of Missouri - Columbia (MU)
Columbia, MO
Full-time
Health Care Provider
Posted on November 9, 2022
Hiring Department
Medical Research – Clinical & Translational Science Unit
Job Description
The primary function of this position is to provide both technical and administrative clinical research support and coordination of clinical trials in the Clinical and Translational Science Units in the NextGen Precision Health building (CTSU East) and the School of Medicine/Hospital space (CTSU West).
Coordinate research subject activities according to clinical trial protocol, applicable regulations, and ICH E6 R2 Good Clinical Practice (GCP) guidelines, and in a manner that maximizes subject retention on clinical trials. In collaboration with Principal Investigator and Clinical Research Nurse, review subjects for changes in condition, adverse events, concomitant medication use, protocol compliance, and response to study intervention.
Collect and document research data for Phase I-IV human subject clinical trials. Responsible for accurate and timely source documentation and reporting of all pertinent aspects of protocol conduct and data in case report forms and sponsor electronic data capture systems. Work with investigators and study staff on clinical trial teams to ensure accurate and compliant records. Participate in the development of approved source documents and protocol tools to enhance clinical trial execution.
Assist with identifying and recruiting research subject participants for a variety of clinical research protocols. Responsible for prescreening, screening, and recruiting potential research subjects in accordance with eligibility requirements. Maintain and submit regular screening logs to sponsors. Organize and maintain recruitment files and research subject files.
Participate in the informed consent process and enroll subjects to clinical trial protocols in accordance with eligibility criteria, as delegated by and under the direction of the Principal Investigator. Schedule and coordinate clinical research subject visits and ancillary tests and procedures according to protocol requirements.
Provide technical support services to investigators and nurses, such as performing EKG, phlebotomy, clinical lab sample collection, processing and shipping samples per IATA regulations, and other technical and research tests/procedures. Responsible for collaboration and training of ancillary personnel, staff, and sub-investigators regarding protocol activities and procedures according to requirements.
Coordinate regulatory activities, including required document maintenance. Prepare and submit Institutional Review Board applications and amendments for clinical research protocols under the guidance of the Principal Investigator and Nurse Manager. Ensure relevant documentation is provided to Institutional Review Boards (local and central) as delegated by Principal Investigator. Prepare, maintain, and submit clinical trial regulatory documents to grant funding agencies and commercial sponsors in compliance with institutional and sponsor regulations and requirements.
Participate in feasibility analyses and program development in collaboration with principal investigators. Participate in and support sponsor site initiation visits and site auditing and monitoring visits, as well as internal monitoring visits.
Work with Office of Medical Research business support staff and Hospital/University Physicians billing staff to ensure correct charges for clinical research services and other project expenses. Identify quality and performance improvement opportunities. Participate in the development and implementation of action plans to improve quality.
Salary
Salary Range: $48,900 - $88,730 Annually
Grade: GGS-010
University Title: Research Consultant
Internal applicants can determine their university title by accessing the Talent Profile tile in myHR.
Shift
8:00AM – 5:00 pm Monday – Friday, with occasional other hours, including evenings, overnights or weekends, as required by study protocols.
Minimum Qualifications
A Bachelor's degree or an equivalent combination of education and relevant experience and at least 3 years of experience from which comparable knowledge and skills can be acquired is necessary.
Preferred Qualifications
Preferred certification in clinical research by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA).
Application Materials
In addition to the Online Application, please provide a Cover Letter and Resume.
Columbia Missouri Information
Columbia, Mo., is known as an ideal college town, combining small-town comforts, community spirit and low cost of living with big-city culture, activities and resources. Home to nationally renowned public schools and other colleges and educational centers, Columbia is packed with restaurants and entertainment venues and hosts more than a dozen annual cultural festivals.
Benefit Eligibility
This position is eligible for University benefits. The University offers a comprehensive benefits package, including medical, dental and vision plans, retirement, paid time off, and educational fee discounts. For additional information on University benefits, please visit the Faculty & Staff Benefits website athttp://www.umsystem.edu/totalrewards/benefits
Diversity Commitment
The University of Missouri is fully committed to achieving the goal of a diverse and inclusive academic community of faculty, staff and students. We seek individuals who are committed to this goal and our core campus values of respect, responsibility, discovery and excellence.
Equal Employment Opportunity
Equal Opportunity is and shall be provided for all employees and applicants for employment on the basis of their demonstrated ability and competence without unlawful discrimination on the basis of their race, color, national origin, ancestry, religion, sex, pregnancy, sexual orientation, gender identity, gender expression, age, disability, protected veteran status, or any other status protected by applicable state or federal law. This policy shall not be interpreted in such a manner as to violate the legal rights of religious organizations or the recruiting rights of military organizations associated with the Armed Forces or the Department of Homeland Security of the United States of America. For more information,call theDirector of Employee and Labor Relations at 573-884-2577.
To request ADA accommodations, please call the Director of Accessibility and ADA at 573-884-7278.
EEO IS THE LAW
To read more about Equal Employment Opportunity (EEO) please use the following links:
- EEO is the LawEnglish Version
- EEO is the LawSpanish Version
- EEO is the LawChinese Version
After careful consideration of COVID-19 virus trends and the overwhelming evidence of COVID-19 vaccine safety and effectiveness, the School of Medicine, along with MU Health Care, the Sinclair School of Nursing and the School of Health Professions, recently announced the decision to require COVID-19 vaccinations by Oct. 1, 2021, for all employees, unless granted a medical or religious exemption.
All new hires will be required to submit proof of vaccination prior to your start date. If you would like to request a medical or religious exemption, you must do so upon acceptance of employment so our team has time to review prior to your scheduled start date. You will not be allowed to begin work until you have submitted proof of vaccination or received an approved medical or religious exemption.
Thank you for helping us to create the safest environment possible for our colleagues, students and our patients by protecting yourself and others through COVID-19 vaccination.